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PIFLUFOLASTAT F-18 | N214793 | PROGENICS PHARMACEUTICALS INC

1 strength6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Nov. 7, 2027

Sep. 21, 2030

Jul. 31, 2029

Jun. 9, 2037

Jun. 9, 2037

Jul. 31, 2029

NCE

May. 26, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

9 trials from ClinicalTrials.gov — 5 recruiting, 3 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer NCT03181867	Phase 2	Active	National Cancer Institute (NCI)	360	2017-08-03 → 2031-02-01
18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer NCT03173924	Phase 2	Active	National Cancer Institute (NCI)	96	2017-06-06 → 2028-02-06
A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer NCT05079698	Phase 1	Active	Memorial Sloan Kettering Cancer Center	29	2021-10-01 → 2027-10
18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy NCT05155046	Phase 2	Recruiting	National Cancer Institute (NCI)	130	2022-08-31 → 2029-12-31
Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer NCT04573231	Phase 2	Recruiting	University of Wisconsin, Madison	13	2021-05-24 → 2026-07
Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL NCT05588128	—	Recruiting	National Cancer Institute (NCI)	350	2023-03-21 → 2027-12-31
A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy NCT06085664	Phase 1/2	Recruiting	M.D. Anderson Cancer Center	42	2023-12-04 → 2028-06-30
PSMA PET for the Staging and Management of Hepatocellular Carcinoma NCT07019844	—	Recruiting	VA Office of Research and Development	90	2024-09-19 → 2028-09-30
Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy NCT03160794	N/A	Completed	University Health Network, Toronto	150	2017-05-23 → 2025-04-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 27, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50ML (1-80mCi/ML)

RLD

6 patents1 exclusivity▴

SOLUTION;INTRAVENOUS | Approved: May 26, 2021

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8487129	Nov 7, 2027	—	Yes	Yes	—	—
8778305	Sep 21, 2030	—	Yes	Yes		—
9861713	Jul 31, 2029	—	Yes	Yes		—
10947197	Jun 9, 2037	—	Yes	Yes		—
11851407	Jun 9, 2037	—	Yes	Yes		—
12070513	Jul 31, 2029	—	Yes	Yes		—

Exclusivities (1)

Code	Date	Status
NCE	May 26, 2026	Expired